| Study characteristics |
| Methods |
RCT |
| Participants |
Setting: Oulu, Finland
N = 160
Sample: birth cohort of women
Age (years): mean 73 (SD 1.2)
Inclusion criteria: hip BMD > 2 less than the reference value
Exclusion criteria: "medical reasons"; use of a walking aid other than a stick; bilateral total hip joint replacement; unstable chronic illness; malignancy; medication known to affect bone density; severe cognitive impairment; involvement in other interventions |
| Interventions |
1. Supervised exercise programme (physiotherapist led). Mixed home and supervised group programme plus twice yearly seminars on nutrition, health, medical treatment and fall prevention
2. Control: twice yearly seminars on nutrition, health, medical treatment, and fall prevention |
| Outcomes |
1. Rate of falls
2. Number sustaining a fracture |
| Duration of the study |
30 months |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "Each participant received sequentially, according to the original identification numbers, the next random assignment in the computer list". |
| Allocation concealment (selection bias) |
Low risk |
The randomisation was "provided by a technical assistant not involved in the conduction of the trial." |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Participants and personnel not blind to allocated group but impact of non‐blinding unclear |
| Blinding of outcome assessment (detection bias)
Falls and fallers |
Low risk |
Falls reported by participants who were aware of their group allocation. Assessors blind to allocation. |
| Blinding of outcome assessment (detection bias)
Fractures |
Low risk |
Fractures reported by participants who were aware of their group allocation. Assessors blind to allocation. Quote: "In the event of a need for medical treatment, the self reported information was checked from the medical records." |
| Incomplete outcome data (attrition bias)
Falls |
Low risk |
SeeAppendix 3 for method of assessment |
| Risk of bias in recall of falls |
High risk |
3‐monthly retrospective recall |
